Business of Medicine

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

Accelerated approvals of oncology drugs based on response data are controversial, because subsequent trials have often failed to show a clinical benefit. This has led to a spate of withdrawals of such accelerated approvals, including those for nivolumab in liver cancer and pembrolizumab in small cell lung cancer.

But one such accelerated approval has now been converted to a full approval, with a small label change, by the Food and Drug Administration.

The new full approval is for pembrolizumab (Keytruda) for first-line use for patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. (The small label change is that mention of PD-L1 status and testing for this have been removed.)

The move is in accordance with recommendations by experts at a recent meeting of the Oncologic Drugs Advisory Committee. They voted 5-3 in favor of this accelerated approval staying. They also voted 10-1 in favor of another immunotherapy, atezolizumab (Tecentriq), for the same indication.

One of the arguments put forward to support these accelerated approvals staying in place is that there is an unmet need in this population of patients who are ineligible for platinum chemotherapy.

But this argument doesn’t hold water – the mere existence of one of these negates the “unmet need” argument for the other, wrote Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Ont., in a commentary on why the FDA’s accelerated approval pathway is broken.

“Even if there is a genuine ‘unmet need’ in a particular setting, these drugs did not meet the standard of improving survival. An unmet need doesn’t imply that the treatment void should be filled with a drug that provides nothing of value to patients,” Dr. Gyawali wrote.

“When we talk about an unmet need, we are speaking of drugs that provide a clinical benefit; any true unmet needs will continue to exist despite maintaining these approvals,” he argued.

After obtaining the accelerated approval for pembrolizumab for patients with bladder cancer who are not eligible for cisplatin-containing chemotherapy, the manufacturer (Merck) carried out a subsequent clinical trial but conducted it in patients who were eligible for platinum-containing chemotherapy (KEYNOTE-361). However, this trial did not meet its prespecified dual primary endpoints of overall survival or progression-free survival in comparison with standard of care chemotherapy, the company noted in a press release.

“We are working with urgency to advance studies to help more patients living with bladder and other types of cancer,” commented Scot Ebbinghaus, MD, vice president of clinical research, Merck Research Laboratories. The company said it has “an extensive clinical development in bladder cancer” and is exploring pembrolizumab use in many settings.

In addition to the new full approval for the first-line indication for patients who are ineligible for platinum chemotherapy, pembrolizumab has two other approved indications in this therapeutic area: the treatment of patients with locally advanced urothelial carcinoma or mUC who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and the treatment of patients with bacillus Calmette-Guérin–unresponsive, high-risk, non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.

A version of this article first appeared on Medscape.com.

Accelerated approvals of oncology drugs based on response data are controversial, because subsequent trials have often failed to show a clinical benefit. This has led to a spate of withdrawals of such accelerated approvals, including those for nivolumab in liver cancer and pembrolizumab in small cell lung cancer.

But one such accelerated approval has now been converted to a full approval, with a small label change, by the Food and Drug Administration.

The new full approval is for pembrolizumab (Keytruda) for first-line use for patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. (The small label change is that mention of PD-L1 status and testing for this have been removed.)

The move is in accordance with recommendations by experts at a recent meeting of the Oncologic Drugs Advisory Committee. They voted 5-3 in favor of this accelerated approval staying. They also voted 10-1 in favor of another immunotherapy, atezolizumab (Tecentriq), for the same indication.

One of the arguments put forward to support these accelerated approvals staying in place is that there is an unmet need in this population of patients who are ineligible for platinum chemotherapy.

But this argument doesn’t hold water – the mere existence of one of these negates the “unmet need” argument for the other, wrote Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Ont., in a commentary on why the FDA’s accelerated approval pathway is broken.

“Even if there is a genuine ‘unmet need’ in a particular setting, these drugs did not meet the standard of improving survival. An unmet need doesn’t imply that the treatment void should be filled with a drug that provides nothing of value to patients,” Dr. Gyawali wrote.

“When we talk about an unmet need, we are speaking of drugs that provide a clinical benefit; any true unmet needs will continue to exist despite maintaining these approvals,” he argued.

After obtaining the accelerated approval for pembrolizumab for patients with bladder cancer who are not eligible for cisplatin-containing chemotherapy, the manufacturer (Merck) carried out a subsequent clinical trial but conducted it in patients who were eligible for platinum-containing chemotherapy (KEYNOTE-361). However, this trial did not meet its prespecified dual primary endpoints of overall survival or progression-free survival in comparison with standard of care chemotherapy, the company noted in a press release.

“We are working with urgency to advance studies to help more patients living with bladder and other types of cancer,” commented Scot Ebbinghaus, MD, vice president of clinical research, Merck Research Laboratories. The company said it has “an extensive clinical development in bladder cancer” and is exploring pembrolizumab use in many settings.

In addition to the new full approval for the first-line indication for patients who are ineligible for platinum chemotherapy, pembrolizumab has two other approved indications in this therapeutic area: the treatment of patients with locally advanced urothelial carcinoma or mUC who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and the treatment of patients with bacillus Calmette-Guérin–unresponsive, high-risk, non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.

A version of this article first appeared on Medscape.com.

Accelerated approvals of oncology drugs based on response data are controversial, because subsequent trials have often failed to show a clinical benefit. This has led to a spate of withdrawals of such accelerated approvals, including those for nivolumab in liver cancer and pembrolizumab in small cell lung cancer.

But one such accelerated approval has now been converted to a full approval, with a small label change, by the Food and Drug Administration.

The new full approval is for pembrolizumab (Keytruda) for first-line use for patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. (The small label change is that mention of PD-L1 status and testing for this have been removed.)

The move is in accordance with recommendations by experts at a recent meeting of the Oncologic Drugs Advisory Committee. They voted 5-3 in favor of this accelerated approval staying. They also voted 10-1 in favor of another immunotherapy, atezolizumab (Tecentriq), for the same indication.

One of the arguments put forward to support these accelerated approvals staying in place is that there is an unmet need in this population of patients who are ineligible for platinum chemotherapy.

But this argument doesn’t hold water – the mere existence of one of these negates the “unmet need” argument for the other, wrote Bishal Gyawali, MD, PhD, from Queen’s University, Kingston, Ont., in a commentary on why the FDA’s accelerated approval pathway is broken.

“Even if there is a genuine ‘unmet need’ in a particular setting, these drugs did not meet the standard of improving survival. An unmet need doesn’t imply that the treatment void should be filled with a drug that provides nothing of value to patients,” Dr. Gyawali wrote.

“When we talk about an unmet need, we are speaking of drugs that provide a clinical benefit; any true unmet needs will continue to exist despite maintaining these approvals,” he argued.

After obtaining the accelerated approval for pembrolizumab for patients with bladder cancer who are not eligible for cisplatin-containing chemotherapy, the manufacturer (Merck) carried out a subsequent clinical trial but conducted it in patients who were eligible for platinum-containing chemotherapy (KEYNOTE-361). However, this trial did not meet its prespecified dual primary endpoints of overall survival or progression-free survival in comparison with standard of care chemotherapy, the company noted in a press release.

“We are working with urgency to advance studies to help more patients living with bladder and other types of cancer,” commented Scot Ebbinghaus, MD, vice president of clinical research, Merck Research Laboratories. The company said it has “an extensive clinical development in bladder cancer” and is exploring pembrolizumab use in many settings.

In addition to the new full approval for the first-line indication for patients who are ineligible for platinum chemotherapy, pembrolizumab has two other approved indications in this therapeutic area: the treatment of patients with locally advanced urothelial carcinoma or mUC who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; and the treatment of patients with bacillus Calmette-Guérin–unresponsive, high-risk, non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.

A version of this article first appeared on Medscape.com.

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Objectivity is tough, but essential: a critical part of patient care, allowing you to make appropriate decisions based on facts and circumstances, not emotions. We’re supposed to be compassionate Vulcans – able to logically weigh possibilities and treatment options under pressure, and at the same time exhibit empathy and sensitivity.

For the most part, all of us become very good at this juggling act. But we’re only human, and once the ability to do that with a given person is lost, it’s gone for good.

Have you ever lost objectivity with a patient? I have. Generally it involves the patient being so difficult, unpleasant, or dislikable that it exceeds my ability to remain impartial and pragmatic in their care.

I don’t know any physician it hasn’t happened to. And when it does, ending the doctor-patient relationship is the only effective answer.

It’s never easy sending that letter, telling someone that they need to seek care elsewhere, and often the specific reason is harder to define. In patients who are overtly rude or noncompliant it’s easy. But often a loss in objectivity is from something less tangible, such as the vagaries of personal chemistry.

I try to get along with all my patients. I really do. That’s part of the job. But sometimes, for whatever reason, it’s just an impossible task. Too many conflicts and differences of opinion over treatments, tests, diagnosis, what they read on Facebook … whatever. When these differences reach a point where they’re an impediment to good patient care … it’s time for both of us to move on.

Regardless of cause, professionalism requires that it be the end of the road. If I can’t objectively weigh a patient’s symptoms and treatment options, then I’m not going to be able to do my very best for them. And my very best is what every patient deserves.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Physicians are bracing for upcoming changes in reimbursement that may start within a few months. As doctors gear up for another wave of COVID, payment trends may not be the top priority, but some “uh oh” announcements in the fall of 2021 could have far-reaching implications that could affect your future.

The Centers for Medicare & Medicaid Services issued a proposed rule in the summer covering key aspects of physician payment. Although the rule contained some small bright lights, the most important changes proposed were far from welcome.

Here’s what could be in store:

1. The highly anticipated Medicare Physician Fee Schedule ruling confirmed a sweeping payment cut. The drive to maintain budget neutrality forced the federal agency to reduce Medicare payments, on average, by nearly 4%. Many physicians are outraged at the proposed cut.

2. More bad news for 2022: Sequestration will be back. Sequestration is the mandatory, pesky, negative 2% adjustment on all Medicare payments. It had been put on hold and is set to return at the beginning of 2022.

Essentially, sequestration reduces what Medicare pays its providers for health services, but Medicare beneficiaries bear no responsibility for the cost difference. To prevent further debt, CMS imposes financially on hospitals, physicians, and other health care providers.

The Health Resources and Services Administration has funds remaining to reimburse for all COVID-related testing, treatment, and vaccines provided to uninsured individuals. You can apply and be reimbursed at Medicare rates for these services when COVID is the primary diagnosis (or secondary in the case of pregnancy). Patients need not be American citizens for you to get paid.

3. Down to a nail-biter: The final ruling is expected in early November. The situation smacks of earlier days when physicians clung to a precipice, waiting in anticipation for a legislative body to save them from the dreaded income plunge. Indeed, we are slipping back to the decade-long period when Congress kept coming to the rescue simply to maintain the status quo.

Many anticipate a last-minute Congressional intervention to save the day, particularly in the midst of another COVID spike. The promises of a stable reimbursement system made possible by the Medicare Access and CHIP Reauthorization Act have been far from realized, and there are signs that the payment landscape is in the midst of a fundamental transformation.

Other changes proposed in the 1,747-page ruling include:
 

Positive:

• More telehealth services will be covered by Medicare, including home visits.
• Tele–mental health services got a big boost; many restrictions were removed so that now the patient’s home is considered a permissible originating site. It also allows for audio-only (no visual required) encounters; the audio-only allowance will extend to opioid use disorder treatment services. Phone treatment is covered.
• Permanent adoption of G2252: The 11- to 20-minute virtual check-in code wasn’t just a one-time payment but will be reimbursed in perpetuity.
• Boosts in reimbursement for chronic care and principal care management codes, which range on the basis of service but indicate a commitment to pay for care coordination.
• Clarification of roles and billing opportunities for split/shared visits, which occur if a physician and advanced practice provider see the same patient on a particular day. Prepare for new coding rules to include a modifier. Previously, the rules for billing were muddled, so transparency helps guide payment opportunities.
• Delay of the appropriate use criteria for advanced imaging for 1 (more) year, a welcome postponement of the ruling that carries a significant administrative burden.
• Physician assistants will be able to bill Medicare directly, and referrals to be made to medical nutrition therapy by a nontreating physician.
• A new approach to patient cost-sharing for colorectal cancer screenings will be phased in. This area has caused problems in the past when the physician identifies a need for additional services (for example, polyp removal by a gastroenterologist during routine colonoscopy).
•  

Not positive:

• Which specialties benefit and which get zapped? The anticipated impact by specialty ranges from hits to interventional radiologists (–9%) and vascular surgeons (–8%), to increases for family practitioners, hand surgeons, endocrinologists, and geriatricians, each estimated to gain a modest 2%. (The exception is portable x-ray supplier, with an estimated increase of 10%.) All other specialties fall in between.
• The proposed conversion factor for 2022 is $33.58, a 3.75% drop from the 2021 conversion factor of $34.89.

The proposed ruling also covered the Quality Payment Program, the overarching program of which the Merit-based Incentive Payment System (MIPS) is the main track for participation. The proposal incorporates additional episode-based cost measures as well as updates to quality indicators and improvement activities.

MIPS penalties. The stakes are higher now, with 9% penalties on the table for nonparticipants. The government offers physicians the ability to officially get out of the program in 2021 because of the COVID-19 pandemic, thereby staving off the steep penalty. The option, which is available through the end of the year, requires a simple application that can be completed on behalf of the entire practice. If you want out, now is the time to find and fill out that application.

Exempt from technology requirements. If the proposal is accepted, small practices – defined by CMS as 15 eligible clinicians or fewer – won’t have to file an annual application to reweight the “promoting interoperability” portion of the program. If acknowledged, small practices will automatically be exempt from the program’s technology section. That’s a big plus, as one of the many chief complaints from small practices is the onus of meeting the technology requirements, which include a security risk analysis, bi-directional health information exchange, public health reporting, and patient access to health information. Meeting the requirements is no small feat. That will only affect future years, so be sure to apply in 2021 if applicable for your practice.

Changes in MIPS. MIPS Value Pathways (MVPs) are anticipated for 2023, with the government releasing details about proposed models for heart disease, rheumatology, joint repair, and more. The MVPs are slated to take over the traditional MIPS by 2027.

The program will shift to 30% of your score coming from the “cost” category, which is based on the government’s analysis of a physician’s claims – and, if attributed, the claims of the patients for whom you care. This area is tricky to manage, but recognize that the costs under scrutiny are the expenses paid by Medicare on behalf of its patients.

In essence, Medicare is measuring the cost of your patients as compared with your colleagues’ costs (in the form of specialty-based benchmarks). Therefore, if you’re referring, or ordering, a more costly set of diagnostic tests, assessments, or interventions than your peers, you’ll be dinged.

However, physicians are more likely this year to flat out reject participation in the federal payment program. Payouts have been paltry and dismal to date, and the buzz is that physicians just don’t consider it worth the effort. Of course, clearing the threshold (which is proposed at 70 points next year) is a must to avoid the penalty, but don’t go crazy to get a perfect score as it won’t count for much. 2022 is the final year that there are any monies for exceptional performance.

Considering that the payouts for exceptional performance have been less than 2% for several years now, it’s hard to justify dedicating resources to achieve perfection. Experts believe that even exceptional performance will only be worth pennies in bonus payments.

The fear of the stick, therefore, may be the only motivation. And that is subjective, as physicians weigh the effort required versus just taking the hit on the penalty. But the penalty is substantial, and so even without the incentive, it’s important to participate at least at the threshold.

Fewer cost-sharing waivers. While the federal government’s payment policies have a major impact on reimbursement, other forces may have broader implications. Commercial payers have rolled back cost-sharing waivers, bringing to light the significant financial responsibility that patients have for their health care in the form of deductibles, coinsurance, and so forth.

More than a third of Americans had trouble paying their health care bills before the pandemic; as patients catch up with services that were postponed or delayed because of the pandemic, this may expose challenges for you. Patients with unpaid bills translate into your financial burden.

Virtual-first health plans. Patients may be seeking alternatives to avoid the frustrating cycle of unpaid medical bills. This may be a factor propelling another trend: Lower-cost virtual-first health plans such as Alignment Health have taken hold in the market. As the name implies, insurance coverage features telehealth that extends to in-person services if necessary.

These disruptors may have their hands at least somewhat tied, however. The market may not be able to fully embrace telemedicine until state licensure is addressed. Despite the federal regulatory relaxations, states still control the distribution of medical care through licensure requirements. Many are rolling back their pandemic-based emergency orders and only allowing licensed physicians to see patients in their state, even over telemedicine.

While seemingly frustrating for physicians who want to see patients over state lines, the delays imposed by states may actually have a welcome effect. If licensure migrates to the federal level, there are many implications. For the purposes of this article, the competitive landscape will become incredibly aggressive. You will need to compete with Amazon Care, Walmart, Cigna, and many other well-funded national players that would love nothing more than to launch a campaign to target the entire nation. Investors are eager to capture part of the nearly quarter-trillion-dollar market, with telemedicine at 38 times prepandemic levels and no signs of abating.

Increased competition for insurers. While the proposed drop in Medicare reimbursement is frustrating, keep a pulse on the fact that your patients may soon be lured by vendors like Amazon and others eager to gain access to physician payments. Instead of analyzing Federal Registers in the future, we may be assessing stock prices.

Consider, therefore, how to ensure that your digital front door is at least available, if not wide open, in the meantime. The nature of physician payments is surely changing.

Ms. Woodcock is president of Woodcock & Associates, Atlanta. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.

©daoleduc/ThinkStock.com

Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.
 

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.
 

Shared responsibility

According to the JAMA commentary, the SAFER guides were developed “to help health care organizations and EHR developers conduct voluntary self-assessments to help eliminate or minimize EHR-related safety risks and hazards.”

In response to a query from this news organization, ONC confirmed that the SAFER guides were intended for use by developers as well as practitioners. ONC said it supports CMS’s approach to incentivize collaborations between EHR vendors and health care organizations. It noted that some entities have already teamed up to the meet the SAFER guides’ recommendations.

Hospitals and EHR developers must share responsibility for safety, Dr. Sittig and Dr. Singh argue, because many SAFER recommendations are based on EHR features that have to be programmed by developers.

For example, one recommendation is that patient identification information be displayed on all portions of the EHR user interface, wristbands, and printouts. Hospitals can’t implement this feature if the developer hasn’t built it into its product.

Dr. Sittig and Dr. Singh suggest three strategies to complement CMS’s new regulation:

• Because in their view, ONC’s EHR certification criteria are insufficient to address many patient safety concerns, CMS should require EHR developers to assess their products annually.
• ONC should conduct annual reviews of the SAFER recommendations with input from EHR developers and safety experts.
• EHR vendors should disseminate guidance to their customers on how to address safety practices, perhaps including EHR configuration guides related to safety.

Safety in EHR certification

At a recent press conference that ONC held to update reporters on its current plans, officials were asked to comment on Dr. Sittig’s and Dr. Singh’s proposition that EHR developers, as well as hospitals, do more to ensure system safety.

Steve Posnack, deputy national coordinator of health IT, noted that the ONC-supervised certification process requires developers to pay attention to how they “implement and integrate safety practices in their software design. We have certification criteria ... around what’s called safety-enhanced design – specific capabilities in the EHR that are sensitive to safety in areas like e-prescribing, medication, and high-risk events, where you want to make sure there’s more attention paid to the safety-related dynamics.”

After the conference, ONC told this news organization that among the safety-related certification criteria is one on user-centered design, which must be used in programming certain EHR features. Another is on the use of a quality management system to guide the creation of each EHR capability.

Nevertheless, there is evidence that not all EHR developers have paid sufficient attention to safety in their products. This is shown in the corporate integrity agreements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) that developers eClinicalWorks and Greenway agreed to sign because, according to the government, they had not met all of the certification criteria they’d claimed to satisfy.

Under these agreements, the vendors agreed to follow “relevant standards, checklists, self-assessment tools, and other practices identified in the ONC SAFER guides and the ICE Report(s) to optimize the safety and safe use of EHRs” in a number of specific areas.

Even if all EHRs conformed to the certification requirements for safety, they would fall short of the SAFER recommendations, Dr. Sittig says. “Those certification criteria are pretty general and not as comprehensive as the SAFER guides. Some SAFER guide recommendations are in existing certification requirements, like you’re supposed to have drug-drug interaction checking capabilities, and they’re supposed to be on. But it doesn’t say you need to have the patient’s identification on every screen. It’s easy to assume good software design, development, and testing principles are a given, but our experience suggests otherwise.”
 

Configuration problems

A handful of vendors are working on what the JAMA article suggests, but there are about 1,000 EHR developers, Dr. Sittig notes. Moreover, there are configuration problems in the design of many EHRs, even if the products have the recommended features.

“For example, it’s often possible to meet the SAFER recommendations, but not all the vendors make that the default setting. That’s one of the things our paper says they should do,” Dr. Sittig says.

Conversely, some hospitals turn off certain features because they annoy doctors, he notes. For instance, the SAFER guides recommend that allergies, problem list entries, and diagnostic test results be entered and stored using standard, coded data elements in the EHR, but often the EHR makes it easier to enter free text data.

Default settings can be wiped out during system upgrades, he added. That has happened with drug interaction checkers. “If you don’t test the system after upgrades and reassess it annually, you might go several months without your drug-drug interaction checker on. And your doctors aren’t complaining about not getting alerts. Those kinds of mistakes are hard to catch.”

Some errors in an EHR may be caught fairly quickly, but in a health system that treats thousands of patients at any given time, those mistakes can still cause a lot of potential patient harm, Dr. Sittig points out. Some vendors, he says, are building tools to help health care organizations catch those errors through what is called “anomaly detection.” This is similar to what credit card companies do when they notice you’ve bought a carpet in Saudi Arabia, although you’ve never traveled abroad, he notes.

“You can look at alert firing data and notice that all of a sudden an alert fired 500 times today when it usually fires 10 times, or it stopped firing,” Dr. Sittig observes. “Those kinds of things should be built into all EHRs. That would be an excellent step forward.”

A version of this article first appeared on Medscape.com.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

Women cardiologists receive dramatically smaller payments from the U.S. Centers for Medicare & Medicaid Services (CMS) than their male counterparts, new research suggests.

An analysis of 2016 claims data revealed male cardiologists received on average 45% more reimbursement than women in the inpatient setting, with the median payment 39% higher ($62,897 vs. $45,288).

In the outpatient setting, men received on average 62% more annual CMS payments, with the median payment 75% higher ($91,053 vs. $51,975; P < .001 for both).

The difference remained significant after the exclusion of the top and bottom 2.5% of earning physicians and cardiology subspecialties, like electrophysiology and interventional cardiology, with high procedural volumes and greater gender imbalances.

“This is one study among others which demonstrates a wage gap between men and women in medicine in cardiology,” lead author Inbar Raber, MD, Beth Israel Deaconess Medical Center, Boston, said in an interview. “I hope by increasing awareness [and] understanding of possible etiologies, it will enable some sustainable solutions, and those include access to additional support staff and equitable models surrounding parental leave and childcare support.”

The study, published online September 8 in JAMA Cardiology, comes on the heels of a recent cross-sectional analysis that put cardiology at the bottom of 13 internal medicine subspecialties with just 21% female faculty representation and one of only three specialties in which women’s median salaries did not reach 90% of men’s.

The new findings build on a 2017 report that showed Medicare payments to women physicians in 2013 were 55% of those to male physicians across all specialties.  

“It can be disheartening, especially as an early career woman cardiologist, seeing these differences, but I think the responsibility on all of us is to take these observations and really try to understand more deeply why they exist,” Nosheen Reza, MD, from the University of Pennsylvania, Philadelphia, and coauthor of the cross-sectional analysis, told this news organization.

Several factors could be contributing to the disparity, but “it’s not gender discrimination from Medicare,” Dr. Raber said. “The gap in reimbursement is really driven by the types and the volume of charges submitted.”

Indeed, a direct comparison of the three most common inpatient and outpatient billing codes showed no difference in payments between the sexes.

Men, however, submitted 24% more median inpatient charges to CMS than women (1,190 vs. 959), and 94% more outpatient charges (1,685 vs. 870).

Men also submitted slightly more unique billing codes (median inpatient, 10 vs. 9; median outpatient, 11 vs. 8).

Notably, women made up just 13% of the 17,524 cardiologists who received CMS payments in the inpatient setting in 2016 and 13% of the 16,929 cardiologists who did so in the outpatient setting.

Louisiana had the dubious distinction of having the largest gender gap in mean CMS payments, with male cardiologists earning $145,323 (235%) more than women, whereas women cardiologists in Vermont out-earned men by $31,483 (38%).

Overall, male cardiologists had more years in practice than women cardiologists and cared for slightly older Medicare beneficiaries.

Differences in CMS payments persisted, however, after adjustment for years since graduation, physician subspecialty, number of charges, number of unique billing codes, and patient complexity. The resulting β coefficient was -0.06, which translates into women receiving an average of 94% of the CMS payments received by men.

“The first takeaway, if you were really crass and focused on the bottom line, might be: ‘Hey, let me get a few more male cardiologists because they’re going to bring more into the organization.’ But we shouldn’t do that because, unless you link these data with quality outcomes, they’re an interesting observation and hypothesis-generating,” said Sharonne Hayes, MD, coauthor of the 2017 report and professor of cardiovascular medicine at Mayo Clinic in Rochester, Minn., where she has served as director of diversity and inclusion for a decade.

She noted that there are multiple examples that the style of medicine women practice, on average, may be more effective, may be more outcomes based, and may save lives, as suggested by a recent analysis of hospitalized Medicare beneficiaries.

“The gap was not much different, like within 1% or so, but when you take that over the literally millions of Medicare patients cared for each year by hospitalists, that’s a substantial number of people,” Dr. Hayes said. “So, I think we need to take a step back, and we have to include these observations on studies like this and better understand the compensation gaps.”

She pointed out that the present study lacks data on full-time-equivalent status but that female physicians are more likely to work part-time, thus reducing the volume of claims.

Women might also care for different patient populations. “I practice in a women’s heart clinic and take care of [spontaneous coronary artery dissection] SCAD patients where the average age of SCAD is 42. So, the vast majority of patients I see on a day-to-day basis aren’t going to be Medicare age,” observed Dr. Hayes.

The differences in charges might also reflect the increased obligations in nonreimbursed work that women can have, Dr. Raber said. These can be things like mentoring, teaching roles, and serving on committees, which is a hypothesis supported by a 2021 study that showed women physicians spend more time on these “citizenship tasks” than men.

Finally, there could be organizational barriers that affect women’s clinical volumes, including less access to support from health care personnel. Added support is especially important, though, amid a 100-year pandemic, the women agreed.

“Within the first year of the pandemic, we saw women leaving the workforce in droves across all sectors, including medicine, including academic medicine. And, as the pandemic goes on without any signs of abatement, those threats continue to exist and continue to be amplified,” Dr. Reza said.

The groundswell of support surrounding the importance of diversity, equity, and inclusion initiatives across the board has helped bring attention to the issue, she said. Some institutions, including the National Institutes of Health, are making efforts to extend relief to women with young families, caregivers, or those in academic medicine who, for example, need extensions on grants or bridge funding.

“There’s certainly a lot left to do, but I do think within the last year, there’s been an acceleration of literature that has come out, not only pointing out the disparities, but pointing out that perhaps women physicians do have better outcomes and are better liked by their patients and that losing women in the workforce would be a huge detriment to the field overall,” Dr. Reza said.

Dr. Raber, Dr. Reza, and Dr. Hayes reports no relevant financial relationships. Coauthor conflict of interest disclosures are listed in the paper.

A version of this article first appeared on Medscape.com.

Following a 2-year investigation, the U.S. government has filed suit against the University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), and James Luketich, MD, for billing related to concurrent surgeries performed by the long-time chair of cardiothoracic surgery.

The lawsuit alleges that UPMC “knowingly allowed” Dr. Luketich to “book and perform three surgeries at the same time, to miss the surgical time outs at the outset of those procedures, to go back-and-forth between operating rooms and even hospital facilities while his surgical patients remain under general anesthesia...”

UPMC, the lawsuit claims, also allowed Dr. Luketich to falsely attest that “he was with his patients throughout the entirety of their surgical procedures or during all ‘key and critical’ portions of those procedures and to unlawfully bill Government Health Benefit Programs for those procedures, all in order to increase surgical volume, maximize UPMC and UPP’s revenue, and/or appease Dr. Luketich.”

These practices violate the statutes and regulations governing the defendants, including those that prohibit “teaching physicians” like Dr. Luketich from performing and billing the U.S. for concurrent surgeries, the Department of Justice said in news release.

The Justice Department contends the defendants “knowingly submitted hundreds of materially false claims for payment” to Medicare, Medicaid, and other government programs over the past 6 years.

“The laws prohibiting ‘concurrent surgeries’ are in place for a reason: To protect patients and ensure they receive appropriate and focused medical care,” Stephen R. Kaufman, Acting U.S. Attorney for the Western District of Pennsylvania, said in the release. 

According to the lawsuit, “some of Dr. Luketich’s patients were forced to endure additional surgical procedures and/or extended hospital stays as a result of his unlawful conduct. Numerous patients developed painful pressure ulcers. A few were diagnosed with compartment syndrome. And at least two had to undergo amputations.”

The allegations were originally brought forward under the federal False Claims Act’s whistleblower provisions by Jonathan D’Cunha, MD, PhD, who worked closely with Dr. Luketich from 2012 to 2019 and now chairs the department of cardiothoracic surgery at the Mayo Clinic, Phoenix.

The charges cited in the lawsuit include three counts of violating the False Claims Act, one count of unjust enrichment, and one count of payment by mistake.

The 56-page lawsuit includes numerous case examples and cites an October 2015 Boston Globe Spotlight Team report on the safety of running concurrent operations, which reportedly prompted UPMC to reevaluate its policies and identify physicians or departments in potential violation.

Hospital officials met with Dr. Luketich in March 2016 and devised a “plan” to ensure his availability and “compliance with concurrency rules,” it alleges, but also highlights an email that notes “continued problems” with Dr. Luketich’s schedule.

“UPMC has persistently ignored or minimized complaints by employees and staff regarding Dr. Luketich, his hyper-busy schedule, his refusal to delegate surgeries and surgical tasks” and “protected him from meaningful sanction; refused to curtail his surgical practice; and continued to allow Dr. Luketich to skirt the rules and endanger his patients,” according to the lawsuit.

The suit notes that Dr. Luketich is one of UPMC and UPP’s highest sources of revenue and that UPMC advertises him as a “life-saving pioneer” who routinely performs dramatic, last-ditch procedures on patients who are otherwise hopeless.

In response to an interview request from this news organization, a UPMC spokesperson wrote: “As the government itself concedes in its complaint, many of Dr. Luketich’s surgical patients are elderly, frail, and/or very ill. They include the ‘hopeless’ patients ... who suffer from chronic illness or metastatic cancer, and/or have extensive surgical histories and choose UPMC and Dr. Luketich when other physicians and health care providers have turned them down.”

“Dr. Luketich always performs the most critical portions of every operation he undertakes,” the spokesperson said, adding that no law or regulation prohibits overlapping surgeries or billing for those surgeries, “let alone surgeries conducted by teams of surgeons like those led by Dr. Luketich.”

“The government’s claims are, rather, based on a misapplication or misinterpretation of UPMC’s internal policies and [Centers for Medicare & Medicaid Services] guidance, neither of which can support a claim for fraudulent billing. UPMC and Dr. Luketich plan to vigorously defend against the government’s claims,” the spokesperson concluded. 

The claims asserted against the defendants are allegations only; there has been no determination of liability. The government is seeking three times the amount of actual damages suffered as a result of the alleged false claims and/or fraud; a sum of $23,331 (or the maximum penalty, whichever is greater) for each false claim submitted by UPMC, UPP, and/or Dr. Luketich; and costs and expenses associated with the civil suit.

A version of this article first appeared on Medscape.com.

Following a 2-year investigation, the U.S. government has filed suit against the University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), and James Luketich, MD, for billing related to concurrent surgeries performed by the long-time chair of cardiothoracic surgery.

The lawsuit alleges that UPMC “knowingly allowed” Dr. Luketich to “book and perform three surgeries at the same time, to miss the surgical time outs at the outset of those procedures, to go back-and-forth between operating rooms and even hospital facilities while his surgical patients remain under general anesthesia...”

UPMC, the lawsuit claims, also allowed Dr. Luketich to falsely attest that “he was with his patients throughout the entirety of their surgical procedures or during all ‘key and critical’ portions of those procedures and to unlawfully bill Government Health Benefit Programs for those procedures, all in order to increase surgical volume, maximize UPMC and UPP’s revenue, and/or appease Dr. Luketich.”

These practices violate the statutes and regulations governing the defendants, including those that prohibit “teaching physicians” like Dr. Luketich from performing and billing the U.S. for concurrent surgeries, the Department of Justice said in news release.

The Justice Department contends the defendants “knowingly submitted hundreds of materially false claims for payment” to Medicare, Medicaid, and other government programs over the past 6 years.

“The laws prohibiting ‘concurrent surgeries’ are in place for a reason: To protect patients and ensure they receive appropriate and focused medical care,” Stephen R. Kaufman, Acting U.S. Attorney for the Western District of Pennsylvania, said in the release. 

According to the lawsuit, “some of Dr. Luketich’s patients were forced to endure additional surgical procedures and/or extended hospital stays as a result of his unlawful conduct. Numerous patients developed painful pressure ulcers. A few were diagnosed with compartment syndrome. And at least two had to undergo amputations.”

The allegations were originally brought forward under the federal False Claims Act’s whistleblower provisions by Jonathan D’Cunha, MD, PhD, who worked closely with Dr. Luketich from 2012 to 2019 and now chairs the department of cardiothoracic surgery at the Mayo Clinic, Phoenix.

The charges cited in the lawsuit include three counts of violating the False Claims Act, one count of unjust enrichment, and one count of payment by mistake.

The 56-page lawsuit includes numerous case examples and cites an October 2015 Boston Globe Spotlight Team report on the safety of running concurrent operations, which reportedly prompted UPMC to reevaluate its policies and identify physicians or departments in potential violation.

Hospital officials met with Dr. Luketich in March 2016 and devised a “plan” to ensure his availability and “compliance with concurrency rules,” it alleges, but also highlights an email that notes “continued problems” with Dr. Luketich’s schedule.

“UPMC has persistently ignored or minimized complaints by employees and staff regarding Dr. Luketich, his hyper-busy schedule, his refusal to delegate surgeries and surgical tasks” and “protected him from meaningful sanction; refused to curtail his surgical practice; and continued to allow Dr. Luketich to skirt the rules and endanger his patients,” according to the lawsuit.

The suit notes that Dr. Luketich is one of UPMC and UPP’s highest sources of revenue and that UPMC advertises him as a “life-saving pioneer” who routinely performs dramatic, last-ditch procedures on patients who are otherwise hopeless.

In response to an interview request from this news organization, a UPMC spokesperson wrote: “As the government itself concedes in its complaint, many of Dr. Luketich’s surgical patients are elderly, frail, and/or very ill. They include the ‘hopeless’ patients ... who suffer from chronic illness or metastatic cancer, and/or have extensive surgical histories and choose UPMC and Dr. Luketich when other physicians and health care providers have turned them down.”

“Dr. Luketich always performs the most critical portions of every operation he undertakes,” the spokesperson said, adding that no law or regulation prohibits overlapping surgeries or billing for those surgeries, “let alone surgeries conducted by teams of surgeons like those led by Dr. Luketich.”

“The government’s claims are, rather, based on a misapplication or misinterpretation of UPMC’s internal policies and [Centers for Medicare & Medicaid Services] guidance, neither of which can support a claim for fraudulent billing. UPMC and Dr. Luketich plan to vigorously defend against the government’s claims,” the spokesperson concluded. 

The claims asserted against the defendants are allegations only; there has been no determination of liability. The government is seeking three times the amount of actual damages suffered as a result of the alleged false claims and/or fraud; a sum of $23,331 (or the maximum penalty, whichever is greater) for each false claim submitted by UPMC, UPP, and/or Dr. Luketich; and costs and expenses associated with the civil suit.

A version of this article first appeared on Medscape.com.

Following a 2-year investigation, the U.S. government has filed suit against the University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), and James Luketich, MD, for billing related to concurrent surgeries performed by the long-time chair of cardiothoracic surgery.

The lawsuit alleges that UPMC “knowingly allowed” Dr. Luketich to “book and perform three surgeries at the same time, to miss the surgical time outs at the outset of those procedures, to go back-and-forth between operating rooms and even hospital facilities while his surgical patients remain under general anesthesia...”

UPMC, the lawsuit claims, also allowed Dr. Luketich to falsely attest that “he was with his patients throughout the entirety of their surgical procedures or during all ‘key and critical’ portions of those procedures and to unlawfully bill Government Health Benefit Programs for those procedures, all in order to increase surgical volume, maximize UPMC and UPP’s revenue, and/or appease Dr. Luketich.”

These practices violate the statutes and regulations governing the defendants, including those that prohibit “teaching physicians” like Dr. Luketich from performing and billing the U.S. for concurrent surgeries, the Department of Justice said in news release.

The Justice Department contends the defendants “knowingly submitted hundreds of materially false claims for payment” to Medicare, Medicaid, and other government programs over the past 6 years.

“The laws prohibiting ‘concurrent surgeries’ are in place for a reason: To protect patients and ensure they receive appropriate and focused medical care,” Stephen R. Kaufman, Acting U.S. Attorney for the Western District of Pennsylvania, said in the release. 

According to the lawsuit, “some of Dr. Luketich’s patients were forced to endure additional surgical procedures and/or extended hospital stays as a result of his unlawful conduct. Numerous patients developed painful pressure ulcers. A few were diagnosed with compartment syndrome. And at least two had to undergo amputations.”

The allegations were originally brought forward under the federal False Claims Act’s whistleblower provisions by Jonathan D’Cunha, MD, PhD, who worked closely with Dr. Luketich from 2012 to 2019 and now chairs the department of cardiothoracic surgery at the Mayo Clinic, Phoenix.

The charges cited in the lawsuit include three counts of violating the False Claims Act, one count of unjust enrichment, and one count of payment by mistake.

The 56-page lawsuit includes numerous case examples and cites an October 2015 Boston Globe Spotlight Team report on the safety of running concurrent operations, which reportedly prompted UPMC to reevaluate its policies and identify physicians or departments in potential violation.

Hospital officials met with Dr. Luketich in March 2016 and devised a “plan” to ensure his availability and “compliance with concurrency rules,” it alleges, but also highlights an email that notes “continued problems” with Dr. Luketich’s schedule.

“UPMC has persistently ignored or minimized complaints by employees and staff regarding Dr. Luketich, his hyper-busy schedule, his refusal to delegate surgeries and surgical tasks” and “protected him from meaningful sanction; refused to curtail his surgical practice; and continued to allow Dr. Luketich to skirt the rules and endanger his patients,” according to the lawsuit.

The suit notes that Dr. Luketich is one of UPMC and UPP’s highest sources of revenue and that UPMC advertises him as a “life-saving pioneer” who routinely performs dramatic, last-ditch procedures on patients who are otherwise hopeless.

In response to an interview request from this news organization, a UPMC spokesperson wrote: “As the government itself concedes in its complaint, many of Dr. Luketich’s surgical patients are elderly, frail, and/or very ill. They include the ‘hopeless’ patients ... who suffer from chronic illness or metastatic cancer, and/or have extensive surgical histories and choose UPMC and Dr. Luketich when other physicians and health care providers have turned them down.”

“Dr. Luketich always performs the most critical portions of every operation he undertakes,” the spokesperson said, adding that no law or regulation prohibits overlapping surgeries or billing for those surgeries, “let alone surgeries conducted by teams of surgeons like those led by Dr. Luketich.”

“The government’s claims are, rather, based on a misapplication or misinterpretation of UPMC’s internal policies and [Centers for Medicare & Medicaid Services] guidance, neither of which can support a claim for fraudulent billing. UPMC and Dr. Luketich plan to vigorously defend against the government’s claims,” the spokesperson concluded. 

The claims asserted against the defendants are allegations only; there has been no determination of liability. The government is seeking three times the amount of actual damages suffered as a result of the alleged false claims and/or fraud; a sum of $23,331 (or the maximum penalty, whichever is greater) for each false claim submitted by UPMC, UPP, and/or Dr. Luketich; and costs and expenses associated with the civil suit.

A version of this article first appeared on Medscape.com.

Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.

Julie Shah, PhD, and Neel Shah, MD

The Shah family

Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources. 

Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.

Suddenly the Shahs had an idea.

“We got a grant together to see if we could augment the nurses by supporting them with computing,” Neel said. “We put a robot on the labor floor. And it worked.”

The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.

“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”

Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.

Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.

“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”

“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”

“He was lonely,” Julie says.

The Shah family

Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.

Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.

Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.

He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.

The Shah family

The Shahs say their personalities are sometimes opposite, but that they balance each other well.

“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
 

In their own words

What is one food that your spouse eats that you can’t stand?

Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.

What is one parenting difference you have?

Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed. 

What’s one quirky thing about your partner?

Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.

Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.

Neel: I live in a Hitchcock movie.

If you weren’t a physician/scientist, what is a dream job you might have?

Julie: I would be a dolphin trainer. That was my childhood dream.

Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.

A version of this article first appeared on Medscape.com.

Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.

Julie Shah, PhD, and Neel Shah, MD

The Shah family

Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources. 

Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.

Suddenly the Shahs had an idea.

“We got a grant together to see if we could augment the nurses by supporting them with computing,” Neel said. “We put a robot on the labor floor. And it worked.”

The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.

“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”

Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.

Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.

“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”

“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”

“He was lonely,” Julie says.

The Shah family

Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.

Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.

Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.

He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.

The Shah family

The Shahs say their personalities are sometimes opposite, but that they balance each other well.

“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
 

In their own words

What is one food that your spouse eats that you can’t stand?

Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.

What is one parenting difference you have?

Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed. 

What’s one quirky thing about your partner?

Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.

Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.

Neel: I live in a Hitchcock movie.

If you weren’t a physician/scientist, what is a dream job you might have?

Julie: I would be a dolphin trainer. That was my childhood dream.

Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.

A version of this article first appeared on Medscape.com.

Medical Power Couples is a new series highlighting spouses or domestic partners prominent in health care. Both have achieved high-level professional success and have made significant contributions to their respective fields.

Julie Shah, PhD, and Neel Shah, MD

The Shah family

Ob.gyn. Neel Shah was telling his wife how challenging it was for labor and delivery nurses to make room assignments: to delegate available beds, predict the timing of patient progression from one room to another, and pair patients with staff nurses, equipment, and resources. 

Julie Shah, a roboticist with Massachusetts Institute of Technology, Cambridge, compared the head nurses to air traffic controllers, but without near the decision support. Julie had previously worked for aerospace giant Boeing, where she helped design a set of algorithmic techniques to give decision support to manufacturing personnel and embed robots to aid their work.

Suddenly the Shahs had an idea.

“We got a grant together to see if we could augment the nurses by supporting them with computing,” Neel said. “We put a robot on the labor floor. And it worked.”

The robot, tested in 2018 at a Boston tertiary care center, produced high-quality recommendations accepted by nurses and physicians 90% of the time. The android was taught to observe actual performances of human tasks – what was done and not done in certain situations – and develop a scheduling policy. The Shahs and their team were the first to field a robotic system on a labor and delivery unit to aid in the coordination of resources required for patient care.

“For the first time, we were able to develop a novel machine-learning technique that could learn from demonstration or observation, heuristics, or strategies for solving resource allocation and scheduling problems, which was really exciting,” Julie said. “We were able to show also how that system could be embedded to offer decision support to reduce the cognitive burden of nurses.”

Neel and Julie joke that their first collaboration dates back to middle school when they sang together in chorus. The Shahs grew up in the same small New Jersey town and met as 14-year-olds.

Though the Shahs have known each other more than half their lives, they haven’t always lived side by side. After they married, Julie accepted an opportunity in Seattle, while Neel remained 3,000 miles away in Boston.

“He does all the cooking, so I did not eat well,” Julie recalled with a laugh. “It was not great.”

“I don’t self-regulate well,” Neel adds. “I just worked 24/7. I started a nonprofit that year, so externally, it looked like I was crushing it, but …”

“He was lonely,” Julie says.

The Shah family

Now back in the same city, the Shahs are doting parents to two toddlers aged 2 and 4, and also serve as heads of house at an MIT graduate dorm.

Julie, 39, is an associate professor in the department of aeronautics and astronautics at MIT and leads the Interactive Robotics Group of the Computer Science and Artificial Intelligence Laboratory. She is renowned for her innovative methods for enabling fluid human-robot teamwork in time- and safety-critical environments such as surgery, manufacturing, and space exploration. In 2014, she was recognized by the MIT Technology Review as one of the world’s top innovators under 35, and her work on industrial human-robot collaboration was recognized as one of the 10 breakthrough technologies of 2013.

Neel, 39, is an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School in Boston and chief medical officer of Maven Clinic, a virtual clinic for women’s and family health. A scientist and entrepreneur, Neel is globally recognized for designing solutions to improve health care. He is founder of Costs of Care, an NGO that curates insights from clinicians and patients to help delivery systems provide better care.

He also cofounded the March for Moms Association, a coalition of organizations that works to raise public and private investment in mothers’ well-being. Most recently, Neel and his team designed TeamBirth, an intrapartum care process that aims to improve the safety and dignity of childbirth care and promote communication and teamwork.

The Shah family

The Shahs say their personalities are sometimes opposite, but that they balance each other well.

“Julie thinks in lists, which sometimes drives me crazy, and I think in exploding clouds, which I think drives her crazy, but the combination usually works out,” Neel said. “We seem to be good complements for each other.”
 

In their own words

What is one food that your spouse eats that you can’t stand?

Neel: She eats raisins, and I hate raisins. Raisins are a crime against humanity. They’re wrong. The chocolate-covered raisins are even grosser.

What is one parenting difference you have?

Julie: Safety. I hover around the kids around safety hazards, and Neel is very relaxed. 

What’s one quirky thing about your partner?

Neel: She has a parrot that predates our marriage. He started out as an illegal dorm bird. He just screeches and poops. If you’re developing a character in a book or a movie and you want to make them seem slightly off, you make them a bird owner. Think about it.

Julie: He’s 19 and his name is Bolivar, after the South American revolutionary. He’s very sweet.

Neel: I live in a Hitchcock movie.

If you weren’t a physician/scientist, what is a dream job you might have?

Julie: I would be a dolphin trainer. That was my childhood dream.

Neel: I’d want to do something creative. I’ve always wanted to be a better musician. I play the guitar and piano.

A version of this article first appeared on Medscape.com.